The present invention relates generally to the field of medicine and in particular aspects to methods and apparatuses for reshaping the esophagus or other body lumens.
Gastroesophageal reflux disease (GERD) has been described as an improper functioning of the lower or inferior esophageal sphincter (LES) in which stomach contents are able to leak back, or reflux, abnormally into the esophagus. When refluxed stomach acid contacts the lining of the esophagus, it causes a burning sensation in the chest or throat called heartburn. Reports show that as many as 10 percent of Americans have daily episodes of heartburn and that up to 44 percent have symptoms at least once a month. While occasional heartburn is common and does not necessarily mean that the subject has GERD, chronic heartburn may signify GERD and can lead to more serious health problems.
Esophagitis, a complication of GERD, can become a relapsing chronic condition. Other complications of GERD include strictures, ulcerations and Barrett's esophagus (progressive replacement of distal eroded squamous mucosa with metaplastic intestinal epithelium). Treatment of GERD may include medication and/or surgery.
Morbid obesity (clinically severe obesity) has been described as a condition in which a person's weight creates major primary or threatened secondary effects on the patient's health and well being. Unfortunately, morbid obesity often results in early death. A 12-year follow-up of 336,442 men and 419,060 women found that the mortality rate increased approximately two-fold for men having a 50% above-average weight, while the mortality rate increased 5-fold for diabetics and 4-fold for those with digestive tract disease in this same group. In a similar group of women, the overall mortality rate also increased two-fold, while the mortality rate increased 8-fold for diabetics and 3-fold for those with digestive tract disease.
Associations between the average weight of population groups and the prevalence of non-insulin-dependent diabetes have also been repeatedly observed. Reports show that the risk of developing diabetes increases about two-fold in the mildly obese, five-fold in the moderately obese and ten-fold in severely obese persons. It is also known that the duration of obesity is an important determinant of the risk for developing diabetes. Further, studies show increases in cancer mortality rates in severely obese females, e.g., endometrium (5.4 times), gall bladder (3.6 times), uterine cervix (2.4 times), ovary (1.6 times) and breast (1.5 times). As well, studies show increases in cancer mortality rates in severely obese males, e.g., colorectal (1.7 times) and prostate (1.3 times).
There remains a need for improved and/or alternative methods and apparatuses that are useful for treating GERD, obesity and other medical conditions. The present invention is addressed to those needs.